Surgical device and method for performing combination revascularization and therapeutic substance delivery to tissue

ABSTRACT

A surgical device is provided for both ablating a channel in a patient&#39;s tissue and also delivering a therapeutic agent. The device includes an elongated multi-lumen tube, an elongated tissue ablating assembly, and a therapeutic agent delivery assembly. The therapeutic agent is capable of being delivered into the channel and/or to the surrounding tissue. The device may further include a second multi-lumen tube also capable of delivering therapeutic agents. A method is also provided for using such a surgical device to ablate a channel in a patient&#39;s tissue and also deliver a therapeutic agent to the tissue, for example, for transmyocardial revascularization or other procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.11/543,505, filed Oct. 5, 2006, and claims the benefit of U.S.Provisional Application No. 60/727,325, filed on Oct. 17, 2005. Theseapplications are incorporated herein by reference.

BACKGROUND

1. Field of the Invention

The present invention relates to a surgical device and method forcreating a channel in a region of tissue and simultaneously or promptlythereafter, delivering a therapeutic agent in, near or around thechannel and more particularly to a device and method for performing atransmyocardial revascularization procedure in combination with deliveryof a therapeutic substance in and around the treated region of themyocardium of the heart.

2. Description of the Prior Art

Living tissue becomes ischemic when starved of oxygen and nutrients,usually because the tissue is not receiving adequate blood supply.Ischemia can be caused by a blockage or narrowing in the vascular systemthat prohibits an adequate supply of oxygenated blood from reaching theaffected tissue area. Ischemia can lead to pain in the area of theaffected tissue and, in the case of certain muscle tissue, can interruptmuscular function. Ischemia is reversible, such that cells may return tonormal function once they receive the proper blood flow. It is believedischemic tissue can remain in a hibernating state, preserving itsviability for some time despite the deprivation of oxygenated blood.Restoring blood flow to the ischemic region is the only known method toaccomplish revival of the ischemic tissue. Although ischemia can occurin various regions of the body, ischemia of the myocardium of the heartis well known due to coronary artery disease or occlusion of thecoronary arteries, which otherwise provide blood to the myocardium.

Atherosclerosis or narrowing of the artery is a leading cause forinadequate blood flow to the heart. In addition to the narrowing,atherosclerosis can result in loose plaque dislodging within an artery.This loose plaque can travel through the arterial system until itbecomes lodged within a narrower portion of the arterial system. Theresulting blockage can lead to an acute infarcted area of themyocardium.

Ischemia and myocardial infarct are two important cardiac diseasestates. Symptoms are those included in the constellation of symptomsreferred to as angina pectoris, and include constricting pain in thechest and radiating pain in the arms, neck and jaw. Ischemia of thetissue of the heart is characterized by limited metabolic processeswhich causes poor functionality, and may lead to fibrillation and death.Thus, the normal contractile functioning of the myocardial heart cellsis hindered in an ischemic region. If an ischemic, or damaged, region ofthe heart does not receive enough blood flow and nutrients to sustainthe myocardial cells, even when in a hibernating state, they are said todie and become infarcted. Infarcted myocardial tissue may also lead tofibrillation and death.

Treatment of myocardial ischemia has been addressed by severaltechniques designed to restore blood supply to the affected region. Oneprocedure, coronary artery bypass grafting (CABG), involves grafting avenous segment between the aorta and the coronary artery to bypass theoccluded portion of the artery. Once blood flow is redirected to theportion of the coronary artery beyond the occlusion, the supply ofoxygenated blood is restored to the area of ischemic tissue.

Ischemic myocardium tissue resulting from atherosclerosis can also betreated through stenting the diseased area of the artery. In thisprocedure, a catheter is passed into the vascular occlusion. A stent isplaced at the occlusion site and expanded within the artery to increasethe vascular opening and increase blood flow. Alternatively, anangioplasty procedure can be performed to open the narrow vascularpassageway. In this procedure, a balloon catheter is passed into theoccluded site and the balloon inflated to increase the vascular opening.While effective to increase blood flow for a period of time, theseprocedures have numerous disadvantages and limitations, including aninability to prevent continued atherosclerosis.

Another method for treating ischemic myocardium is calledtransmyocardial revascularization (“TMR”), the creation of pathways orchannels in the myocardium of the heart. The procedure using needles ina form of surgical “myocardial acupuncture” has been used clinicallysince the 1960s. In this method, small channels are created eithercompletely through the myocardium in an open surgical procedure orpartially through the myocardium from the endocardial layer in apercutaneous procedure. Various modalities may be used to create thesechannels, including mechanical means, laser energy, radiofrequencyenergy, ultrasonic energy, resistive heating, and cryoablation. Thesechannels may create an area of injury that is believed to spur thenatural healing process. A desirable part of this healing process is thecreation of new blood vessels that may help to alleviate the ischemiccondition within the myocardium.

Yet another method to treat ischemic tissue, and particularly ischemicmyocardial tissue, is through therapeutic agent therapy. Therapeuticagent therapies with angiogenic and myogenic growth factors may expediteand/or augment collateral artery development. In the field oftherapeutic agent delivery, many techniques currently exist fordelivering therapeutic agents or other materials including, but notlimited to, biologics to the human body. These include, among others,oral administration, injection directly into body tissue such as throughan intramuscular injection, transcutaneous injection in which a compoundis injected directly into the vasculature of a patient, or topicaladministration. Although many situations are satisfactorily treated bythe general or directed, typically systemic acting administration of atherapeutic agent, the treatment of ischemic tissue could be facilitatedand/or improved by the ability to deliver or administer a biologic agentdirectly to or adjacent such tissue with control over such delivery.Recently, medicine has focused attention on treating diseases withconventional physical surgical procedures in combination with a localdelivery of a drug or other therapeutic agent. For example U.S. Pat. No.6,224,584, issued on May 1, 2001 to March, et al., which is herebyincorporated by reference in its entirety into this application,discloses a system for treating a patients heart by first formingchannels in the heart and then delivering drugs or other therapeuticagents into those channels.

There are a number of important problems that are not addressed by thesystems and methods of the present art. For example, none of the priorart teaches how to ablate a channel into a desired tissue and eithersimultaneously, or in various sequences, administer a therapeutic agentor any combination of agents into both the channel and into the tissuesurrounding the channel. Moreover, the prior art does not teach a deviceand method for precise and effective ablation along with simultaneouscontrolled delivery of the desired agent or agents into the channel andsurrounding tissue. None of the prior art systems discloses a devicethat allows for a surgeon to perform a combination TMR and directdelivery of a therapeutic agent using a single simple device and in thesame procedure.

BRIEF SUMMARY

In general, this invention is directed toward a surgical device forablating tissue and delivering a therapeutic agent both in and near oraround the ablated tissue. More specifically, this invention is directedto a system and method for creating a channel in a region of tissue andsimultaneously or immediately thereafter, delivering a therapeutic agentin, near or around the channel.

The present invention comprises a device for treating tissue by creatinga pathway, opening or channel in the tissue and delivering a therapeuticagent or agents into the channel with the ability to also deliver eitherthe same or different therapeutic agents into a region of the tissueadjacent the channel. The surgical device includes an elongatedmulti-lumen delivery tube having a proximal end connected to a controlhandle assembly and extending outwardly to a treatment assembly at thedistal end. An elongated tissue ablating assembly is housed andsupported in a first lumen of the multi-lumen delivery tube. Theablating assembly extends through the delivery tube to an ablating tipat the treatment assembly. The ablating assembly is adapted fordelivering an ablating means, such as a lasing energy from a source,such as a laser, to the ablating tip. The ablating tip is specificallydesigned for creating a channel, bore or other pocket into the tissue.

The multi-lumen delivery tube also houses and supports an elongatedtherapeutic agent delivery assembly in a second lumen. The deliveryassembly has a proximal end adapted for connection with a source of thetherapeutic agent or agents and extends distally through the secondlumen to a delivery tip. The agent delivery assembly is adapted fortransferring the therapeutic agent from the source to the delivery tipwhere it is dispensed into the tissue. The ablating tip and delivery tipare located adjacent each other at the distal end of the multi-lumentube such that the therapeutic agent can be delivered into a channelformed by the ablating tip. Preferably dispensing can occur withouthaving to remove the ablating tip from the channel.

In another embodiment of the present invention, the surgical devicefurther includes a second elongated multi-lumen delivery tube. Thesecond multi-lumen tube includes a plurality of lumens with the firstmulti-lumen tube extending through a first or main lumen. The secondmulti-lumen delivery tube also has at least one additional lumen that isconnected with an injection receiving port at a proximal end forconnection with a source of therapeutic agent or agents. The secondlumen of the second delivery tube extends from the injection receivingport to a second therapeutic agent delivery tip at a distal end. Thesecond lumen of the multi-lumen tube is adapted for delivering thetherapeutic agent from the source to the second delivery tip. The firstmulti-lumen delivery tube extends through and is slideable within themain lumen of the second multi-lumen delivery tube. In this way, thefirst multi lumen tube along with the ablating and first delivery tipcan be advanced into the tissue so as to ablate and create a channel anddeliver a first therapeutic agent independently of the therapeuticdelivery tip of the second lumen of the second multi lumen device.

The present invention further comprises a method for performing acombination myocardial revascularization procedure and delivering atherapeutic agent to a desired region of the myocardial heart tissuecomprising the steps of first providing a surgical device having a firstelongated multi-lumen tube with a proximal end in connection with acontrol handle assembly and extending to a distal treatment end. Thefirst multi-lumen tube has a tissue ablating assembly extending througha first lumen of the multi-lumen tube and a therapeutic agent deliveryassembly extending through a second lumen of the multi-lumen tube. Theablating assembly itself is connected to a source of ablating energy,such as a laser, at its proximal end and extends distally through thefirst lumen to an ablating tip at the end of the first multi-lumen tube.The ablating tip is adapted for creating a channel in the myocardialtissue such as a revascularization channel. The therapeutic agentdelivery assembly includes a therapeutic agent injection receiving orinfusion port at a proximal end and extends through the second lumen ofthe first multi-lumen tube to a delivery tip disposed proximally to theablating tip such that the therapeutic agent can be delivered into thechannel. And can even be accomplished without having to remove or fullyretract the ablating tip from the channel.

A second elongated multi-lumen tube is aligned along the same generalaxis as the first multi-lumen tube. Both the first multi lumen tube andthe second multi lumen delivery tube are slideably supported within andextend through a rigid or semi rigid guide tube that is connected at aproximal end to the handle assembly. The second multi-lumen tube has aproximal end in fluid connection with a second therapeutic agent andextends to an injection tip. The injection tip is adapted for deliveringthe second therapeutic agent into the myocardial tissue adjacent thechannel.

The guide tube of the surgical device is then inserted into a patientand the treatment end, including the ablating, delivery and injectiontips, is positioned adjacent the desired region of tissue. This istypically accomplished surgically with the surgeon physically locatingthe treatment end as desired through manipulation of the handleassembly. Once the treatment tip is located, the source of ablatingenergy is energized such that the ablating tip is capable of ablatingthe tissue. For example, a laser might be energized. The ablating tip isthen advanced into the myocardial tissue to form a channel in thedesired region. The injection tip is then advanced into the desiredregion of tissue adjacent the channel and therapeutic agent is dispensedfrom both the delivery tip into the channel and the injection tip intothe region of tissue adjacent the channel.

In another embodiment of the procedure of the present invention, theinjection tip is advanced into the myocardial tissue prior to advancingthe ablating tip into the tissue to create a channel. A secondtherapeutic agent may be delivered from the injection tip into thetissue prior to forming the channel.

In another embodiment of the surgical device and procedure of thepresent invention, the surgical device further includes an elongated andat least partially flexible guide tube having a steering mechanismadapted for directing the distal end and treatment tip. The steeringmechanism may be advantageously adapted such that the surgical device isuseable with minimally invasive ports.

In yet another embodiment of the present invention, the surgical deviceand procedure are adapted for use on desired regions of tissue otherthan myocardial tissue.

Other objects, advantages and features of the present invention will beapparent to those of skill in the art from the following detaileddescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the various embodimentsdisclosed herein will be better understood with respect to the followingdescription and drawings, in which like numbers refer to like partsthroughout, and in which:

FIG. 1 is a representative schematic view of a preferred embodiment ofthe present invention.

FIG. 2A is a representative side view of a distal portion of thesurgical device of the present invention.

FIG. 2B is a representative perspective view of the distal end of thesurgical device of the present invention.

FIG. 2C is a representative side top view of an embodiment of the distalend of the surgical device of the present invention.

FIG. 3A is a representative cross sectional view of the handle and guidetube assembly of the present invention.

FIG. 3B is a representative cross sectional view of the guide tube,nosecone and actuator of the present invention.

FIG. 4A is a representative side view of the preferred embodiment of theguide tube of the present invention.

FIG. 4B is a representative cross sectional view of the preferredembodiment of the guide tube of the present invention.

FIG. 5 is a representative cross sectional view of the preferredembodiment of the multiple lumen ablating tube of the present invention.

FIG. 6A is a representative side view of the preferred embodiment of themulti-lumen therapeutic agent delivery tube of the present invention.

FIG. 6B is a representative cross sectional view of a preferredembodiment of the multi-lumen tube of the present invention.

FIG. 7 is a representative partial top view of the handle controlassembly of an alternative embodiment of the surgical device of thepresent invention.

DETAILED DESCRIPTION

While a variety of embodiments of the present invention are disclosedherein, one exemplary and the presently preferred embodiment of thesurgical device is illustrated generally as reference number 10 inFIG. 1. This embodiment of the surgical device 10 is particularlysuitable for procedures for treating the heart, and particularly forperforming transmyocardial revascularization (“TMR”), biopsy and relatedprocedures to a desired region of tissue in combination with thesimultaneous or near simultaneous delivery of a therapeutic agent intochannels formed by the TMR procedure as well as in the surroundingtissue. The illustrated dimensions are for such a TMR and therapeuticagent delivery device and procedure.

As will be discussed in greater detail, the therapeutic agent or agentsmay include a drug to facilitate the procedure such as a numbing agent,pain controlling substance or even a blood conditioner. Alternatively,the therapeutic agent may include a biologic agent to facilitate theprocedure or recovery or even to facilitate desired results, including,but not limited to the delivery of angiogenic agents, growth factors,stem cell substances, antiarrythmic agents, chemotherapy agents, bloodconditioners and even pain treating agents. The instant device andprocedure further contemplate delivering multiple therapeutic agents,including delivering agents for each aspect of the procedure as well asfor delivering multi-component treatments and reagents and in varyingquantities, forms and dosages.

The terms “therapeutic agent,” “agent,” “drug” and biologic agent” shallbe interchangeable for the purposes of this invention and disclosure andshall include any and all agents which could or will be used in themanners described herein, including and not limited to medications,drugs, antibiotics, vaccines, function regulators, chemotherapy agents,growth factors, stem cells, other materials for performing functionsincluding flushing and cooling, stimulating other responses, detection,analysis, monitoring, visualization or control, etc. The presentinvention further contemplates the delivery of therapeutic agents asliquid, solid, semi-solid, gel, cream, gas and also in any variety offormulation, including time release formulations, impact formulations,etc. A more detailed description of such drugs and methods ofadministering them is disclosed in U.S. Pat. No. 5,999,678 issued onDec. 7, 1999 to Murphy-Chutorian, et al., which disclosure isincorporated herein in its entirety by this reference. Referring nowback to FIG. 1, the surgical device 10 is preferably adapted for handuse and manipulation and may be held in several positions using one orboth hands. The device includes a handle assembly 12. A guide tubeassembly 14 extends distally from the handle 12 to a distal end 16 whichmay include a stabilizing cup or ring 16. The stabilizing cup 16 isadapted for placement against the desired region of tissue to betreated. In the currently preferred embodiment for TMR procedure, thesurgical device 10 does not include the stabilization ring 16. Anablating tip 18 and a first therapeutic agent delivery tip 20 aredisposed within the open diameter of the distal end of the guide tube16. A second therapeutic agent delivery means 22, for example atherapeutic agent injection tip assembly, is also located within theopen diameter of the guide tube 14.

A first therapeutic agent delivery means 24 is adapted for deliveringand dispensing a therapeutic agent or therapeutic agents from the firsttherapeutic agent delivery tip 20. The first therapeutic agent deliverymeans 24 includes a therapeutic agent receiving port 26 at a proximalend that is connected to at least one lumen of a multi-lumen deliverytube 28 (not shown). The multi lumen delivery tube 28 extends throughthe handle 12 and guide tube assembly 14 to a dispensing orifice on thefirst therapeutic agent delivery tip 20. As will be discussed further,the first therapeutic agent delivery means 24 may include one, two ormore therapeutic agent receiving ports 26, such as an injection port,with each having a separate and independent conduit 30 connecting eachreceiving port with the first therapeutic agent delivery tip 20. Thefirst therapeutic agent delivery tip 20 may further be adapted withmultiple orifices, each connected and corresponding to an independentconduit 30 and lumen within the multi lumen delivery tube such thatmultiple therapeutic agents or differing application techniques may beindependently administered through the first therapeutic agent deliverytip 20.

An injection device 32, such as an injection needle may be used as asource of each desired therapeutic agent and to also create sufficientpressure to deliver the agent to and out of the delivery tip 20. In theevent multiple therapeutic agents are to be administered, each can bedelivered from an independent injection or similar device 32.

The preferred embodiment of the surgical device also includes a secondtherapeutic agent delivery means 34. This second therapeutic agentdelivery means 34 also includes a therapeutic agent receiving port 36,such as an injection port that is similarly connected to a conduit 60for transferring the therapeutic agent or therapeutic agents from thereceiving port to a second multi lumen delivery tube 38 (not shown). Thesecond multi lumen delivery tube 38 passes through the handle 12 andguide tube assembly 14 and terminates at the second delivery orinjection tip 22. The second therapeutic agent delivery means 34,similar to the first therapeutic agent delivery means 24, may includemultiple injection ports 36, each having a separate conduit 60 fordelivering the particular therapeutic agent to the second delivery tip22 or to a unique delivery port on the second delivery tip.

A source of ablating energy 40 is connected to the ablating tip 18through an energy transferring means 42. In the preferred embodiment,the source of ablating energy 40 is a laser and the preferred means fortransferring the laser energy is through a fiber optic 42. The source ofablating energy 40 and corresponding means of transferring that energy42, may also include, but are not limited to, radiofrequency energy,cryo-energy and cryoablation, ultrasound, mechanical means, such asrotating or vibrating energy and a shaft, as well as any other energyand means of transferring that energy or any other method of ablatingtissue.

Referring now to FIGS. 2A through 2C, the preferred embodiment of thesurgical device 10 is shown in greater detail. Specifically, surgicaldevice 10 includes a handle assembly or hand piece 12 which is a moldedor machined piece and preferably molded from a plastic material. Thehand piece 12 defines a contoured surface and may include one or morefinger grip indentations. Preferably, the contoured surface providestactile feedback regarding the position of the hand on the device 10 andrelative to the ablating tip 18 and therapeutic agent delivery tip 20 sothe physician need not look away from the medical procedure or othertask at hand. The contoured surface further assists the surgeon tosecurely hold the hand piece without slippage in at least two, differentpositions during either left or right handed operation of the device 10.An elongated neck portion or nosecone 44 is coupled to and extends fromthe hand piece 12. The nosecone 44 may be a separate component thatallows for a rotary connection with the hand piece 12. As such, thenosecone 44 may include a contoured or gripping surface, includehandling tabs. The nosecone 44 may also be constructed from a molded ormachined plastic similar to the hand piece 12, or similarly may beconstructed from other materials such as metal or composite materials.

The hand piece 12 extending into the nosecone 44 includes a continuousbore or passageway which the first multi lumen delivery tube 28 and thesecond multi lumen delivery tube 38 pass through. Alternatively, thehousing 12 may only support a portion of each delivery tube 28 and 38.An actuator assembly 46 is coupled to the handle assembly 12. Thepreferred actuator 46 is a finger slide actuator used for advancing andretracting the treatment tips 18, 20 and 22. Alternatively, the handle12 and even the nosecone 44 may be fitted with any number of actuatorsfor such extension and retraction or other functions, includingcontrolling the delivery of agents into the tissue. One such alternativeembodiment is described in FIG. 7. In this embodiment, the firstactuator 46 is used to advance and retract the ablating tip 18 while asecond actuator 48 is used to advance and retract the injection orsecond therapeutic agent delivery tip 22. The single actuator, however,advantageously provides a simpler and less surgically complex device.Alternatively, the treatment tips 18, 20 and 22 may also be moveableusing most any form of mechanical, electro-mechanical slide mechanism ormay even be moved using an automated mechanism.

Referring now to FIGS. 2A through 3B, the actuator 46 is mechanicallyconnected to the first multi lumen tube 28 and the second multi-lumentube 38 such that actuation causes movement of these tubes through theguide tube 14. In the preferred embodiment, the surgical device 10 isprovided with the actuator 46 in a retracted position with it beingadvanced forward into a fully actuated position by the surgeon duringperformance of the desired surgical procedure. As the actuator 46 ismoved forward, it initially solely advances the first multi-lumen tube28 which necessarily advances the ablating tip 18 and therapeutic agentdelivery tip 20. This movement advantageously allows the surgeon tocommence the ablation of tissue without advancing the injection tip 22.As the actuator 46 is further advanced, the second multi-lumen tube 38is engaged and advanced along with the continuing advancement of thefirst multi-lumen tube 28. In this way, as the actuator 46 is advanced,first only the ablating 18 and therapeutic agent delivery tip 20 areadvanced and then the injection tip 22 is also advanced. In thepreferred embodiment for TMR procedures, actuation by this method isadvantageous because the ablating tip 18 is required to be translatedconsiderably further than the injection tip 22.

The guide tube 14 is a tubular sleeve that extends outwardly from itsconnection with the nosecone 44. Preferably, the guide tube 14 isrigidly attached to the nosecone 44 and extends into a curved distalportion 50. A stabilizing cup 16 may be attached to the distal end ofthe curved portion 50 for certain applications. The guide tube 14 may beconstructed of metal, plastic or composite materials and may be even bemalleable to allow some flexibility or made from a plastic for greaterflexibility.

Referring now to FIGS. 5A and 5B in conjunction with FIGS. 2A through3B, the preferred embodiment of the guide tube 14 is made from a thinmedical grade stainless steel tube. The interior diameter of the guidetube 14 is sufficient to allow for slideable movement of the secondmulti-lumen tube 38 extending there through. Preferably, the insidediameter is coated or lined to reduce friction against the outerdiameter of the second delivery tube 38. In the preferred embodiment,the interior of the guide tube 14 is spray coated with low frictionmaterial such as PTFE. Alternatively, the guide tube 14 may be coated orlined with any other friction reducing material, including an oil,grease, powder, polymer, etc. The friction reducing coating facilitatesactuation of the actuator 46 and movement of the second multi-lumen tube38 within the guide tube 14.

As shown, the guide tube 14 extends away from the nosecone 44 to thecurved distal portion 50 which in the preferred TMR embodiment has acurve of approximately 75 degrees from its longitudinal axis. The curvedportion 50 advantageously allows positioning of the treatment tips 18,20 and 22 against the desired tissue. Depending on the procedure or eventhe surgeon's preferences, the guide tube 14 can be provided with acurved portion 50 of almost any angle and angle of curvature, includenot having any curvature. Alternatively, the guide tube 14 may beconstructed from a malleable material, semi rigid or flexible materialsuch that the curved portion 50 may be adjustable.

Referring now to FIGS. 3A and 3B, the guide tube 14 terminates distallyat the distal end 16, which may include a stabilizing cup assembly 16.The stabilizing cup 16 is generally cup or disc shaped and is designedto contact tissue and maintain contact and alignment of the treatmenttips 18, 20 with the region of tissue being treated. The stabilizing cup16 may be constructed from generally yieldable materials such assilicone, soft elastic, rubber or foam and may also be metallic orplastic. The stabilizing cup 16 includes a bore aligned and inconnection with the bore formed through the guide tube 14. In this way,the treatment tips 18, 20 and 22 can freely pass through the guide tube14 as well as the stabilizing cup 16.

Preferably, the stabilizing cup 16 is cone shaped and is made from amedical grade polyether block co-polymide polymer (“Pebax”) or othermedical grade polymer that is sufficiently pliable to form a contactsurface with the tissue being treated and is also bondable to the distalend of the guide tube 14. Alternatively the stabilizing and locating cup16 may be detachable with conventional snap fit or screw mountmechanisms and may be designed with differing outer diameters toaccommodate different treatment procedures as well as differing accessports. The stabilizing cup 16 may also be advantageously used to allowfor a suction or pressure sealing surface against the tissue with thevacuum source or pressure supply provided from a lumen of one of themulti-lumen tubes 28 or 38 or even from the guide tube 14. Thestabilizing cup 16 may be omitted in applications, such as the presentlydescribed TMR application, where the downside from the increaseddiameter to the guide tube 14 is outweighed by the provided advantages.

FIG. 5 shows a cross sectional view of the first or inner flexiblemulti-lumen delivery tube 28 that is supported within and extendsthrough the guide tube 14. Preferably, the first delivery tube 28 ismade from an extruded polymer such as Pebax but could also be made fromalmost any medical grade material with sufficient wall strength tosupport multiple small diameter lumens as well as be flexible. The firstmulti-lumen tube 28 includes a first lumen 52 for supporting theablating means. In the preferred TMR embodiment, the ablating means islaser energy and the first lumen 52 supports a fiber optic bundle(multifilament or monofilament) connected to a laser source 40 andadapted for delivering the laser energy from the laser through the firstlumen to the ablating tip 18. The fiber optic is preferably bondedwithin the first lumen 52 but may also be fixed through heat or chemicalshrinkage of the tube 28 or through a friction fit, wedging or the like.In this way, extending the first multi-lumen tube 28 relative to theguide tube 14 also moves the fiber optic and the ablating tip 18 aswell. In the preferred embodiment, the fiber optic is bonded at thedistal end of the first lumen 52 adjacent the ablating tip 18.

The first multi lumen tube 28 also includes at least one additionallumen 54 running generally alongside the first lumen 52 for delivery ofone or more therapeutic agents from a source to the delivery tip 20. Inthe preferred TMR embodiment shown, two additional or secondary lumens54 are provided with each terminating into the distal orifice ordelivery tip 20. Multiple secondary lumens 54 also allow for deliveringcombinations of therapeutic agents or even epoxy-type materials thatreact when mixed. For example, platelet rich plasma may be mixed with athrombin solution. When mixed, this solution will gel. Therefore, it ispreferable to deliver these agents separately and allow them to mixafter dispensing from the delivery tip 20.

The secondary lumens 54 deliver the therapeutic agent by directlydispensing through orifices at the distal end of the delivery tip 20.The delivery tip 20 may simply be the natural orifice at the very distalend of the secondary lumen 54 or a modified diameter orifice.Alternatively, the delivery tip 20 may be an injection needle connectedto the lumen 54 or a tip specifically designed for the specificprocedure or therapeutic agent being delivered.

In yet another embodiment, the distal end of one, or more if there aremultiple delivery tips 20, may be capped or effectively capped with thedispensing orifice or orifices provided along the side of the deliverytip. In this configuration, the distal ends of the secondary lumens 54are capped and an orifice or orifices are provided along the side of thelumen so as to deliver the agent out of the side of the tip. Preferably,side orifices will be placed so that any side delivery will be at leastpartially if not fully within the expected depth of the ablated channel.Delivery to the side may be advantageous in terms of helping to ensurethat the therapeutic agent remains in the ablated channel. There alsomay be an advantage in creating a partial thickness channel to ensurethat the agent remains within the channel created.

Capping or occluding, including partial occluding, of the distal end ofthe delivery tip 20 for side delivery of the therapeutic agent can beaccomplished by either introducing a bond agent into the smallersecondary lumens 54 or alternatively by heating the end of themulti-lumen tubing 28. By heating to the melt temperature of theextruded tubing, the secondary lumens 54 can be melted and collapsed.Once the distal portions of the secondary lumens 54 are occluded ormelted, a small hole 20 or preferably multiple small holes can be cut,drilled, machined or notched into the secondary lumens 54 proximal tothe occluded distal end. A small hole can also be provided at the verydistal end or tip. Preferably, the side delivery holes 20 are placed farenough proximally so that the larger profile of the multi-lumen designdoes not interfere with the creation of the ablated channel.

The very end of the multi-lumen delivery tube 28 can be scalloped orskived away just past the occlusions made in the secondary lumens 54 toallow the ablating tip 18 to effectively protrude distally.Alternatively, the ablating tip 18 can be bonded so it protrudes fromthe distal end of the multi-lumen tube 28. After the treatment tip 18 isadvanced through some tissue, such as the myocardium, furtheradvancement of the first delivery tube 28 and treatment tip 18 willallow the side holes of the delivery tip 20 and the relatively largerouter diameter of the first delivery tube 28 to be properly locatedwithin the ablated channel.

It should be understood that although the present invention disclosesand contemplates a second delivery tube 38 supported within the guidetube 14, it is not a required feature for certain inventive aspects ofthe present invention. For example, a surgical device 10 having a singlemulti-lumen tube 28 with multiple therapeutic agent delivery lumens 54and tips 20 may be advantageous in many procedures. Moreover, thisdesign would allow for a much smaller diameter and less invasive guidetube 14 and also for an improved catheter based version for intravascular and minimally invasive surgeries. In a single delivery tube 28embodiment, the multi-lumen tube 28 is slideably supported within theguide tube 14 but without excess space so as to increase the overalldiameter of the guide tube. To facilitate a frictionless surface, thetube 28 may be coated with a friction reducing layer such as a PTFE oreven a medical grade oil or grease or silicone.

FIGS. 6A and 6B illustrate various views of the second flexible multilumen delivery tube 38 which is adapted for carrying the first deliverytube 28 and for providing a secondary means of therapeutic agentdelivery 34. Similar to the first delivery tube 28, the second deliverytube 38 is preferably made from a Pebax material or other medical gradeextruded plastic. Preferably, the second delivery tube 38 is amulti-lumen tube 28 that is slideably supported within the guide tube 14but without excess space so as to increase the overall diameter of theguide tube. To facilitate frictionless surfaces, the delivery tube 38and/or the inner diameter of the guide tube 14 may be coated with afriction reducing layer such as a PTFE or even a medical grade oil orgrease or silicone. The second delivery tube 38 is preferably proximallyconnected to the actuator 46 and extends through the guide tube 14 andstabilizing cup 16 to the second delivery tip 22.

The second multi-lumen delivery tube 38 includes a main or first lumen56 which is adapted for supporting at least a portion of the firstdelivery tube 28. Preferably, the first delivery tube 28 is slideablysupported and extends through the main lumen 56 of the second multilumen delivery tube 28. In this way, the first delivery tube 28,including the fiber optic and ablating tip 18 can be extended orretracted independently of the second delivery tube 38 and the guidetube 14. The second delivery tube 38 also includes an additional orsecond lumen 58 adapted for delivering a therapeutic agent from a sourceto the second delivery tip 22. Preferably, the second lumen 58 isconnected to the therapeutic agent receiving port 36 either directly orthrough a conduit 60 at the proximal end. The source of therapeuticagent may be the same therapeutic agent provided to the first deliverytube 28 or may be entirely different. For example, the second deliverytube 38 may be used to deliver a desensitizer which is injected into thetissue prior to ablating or could even be a blood coagulator that isdelivered promptly after ablation. This disclosure is in no way intendedto limit the various combinations of therapeutic agents that could bedelivered through each of the first delivery tip 20 and the seconddelivery tip 22 or the various sequences of delivery of such agent.

In the preferred embodiment, the second delivery tube 38 includes threespaced apart secondary lumens 58. The main lumen 56 extends coaxiallywith the delivery tube 38 and the three secondary lumens 58 are equallyspaced radially and circumferentially from the main lumen. Each of thesecondary lumens 58 is jointly connected to a single therapeutic agentinjection port 36 for delivering the therapeutic agent through a syringeor similar device. Although only a single injection port 36 is used inthis embodiment for connection with multiple secondary lumens 58, anynumber of such ports or similar devices may be used, including usingseparate delivery conduits 60 and injection port 36 for each secondarylumen 58. A therapeutic agent receiving or injection port 36 or similarsource of therapeutic agent could also be directly coupled to eachsecondary lumen 58.

Alternatively, any means of connecting a source of therapeutic agent tothe secondary therapeutic agent delivery lumen 58 or to the secondtherapeutic agent delivery lumens 54 of the first delivery tube 28 maybe used. For example a therapeutic agent infusion device could bedirectly coupled to any one or all of the delivery conduits 30 or 60 oreven directly to the therapeutic agent delivery lumens 54 and 58.Therapeutic agent infusion devices would allow for precise dispensing ofthe therapeutic agent and controlled pressure of distribution.Similarly, any method of either singularly providing the therapeuticagent or individually providing the therapeutic agent to each lumen 58may be provided as is known in the art such as through medical tubing60.

Referring now to FIGS. 1 though 6B with particular emphasis on FIG. 2B,the distal end of the secondary lumen 58 or in the preferred embodiment,the three secondary lumens, are connected to the second therapeuticagent delivery tip 22. In the preferred embodiment, the therapeuticagent delivery tip comprises an injecting device 32 coupled to eachsecondary lumen 58. Similar to the therapeutic agent receiving port 36at the proximal end, each secondary therapeutic agent delivery lumen 58may be connected to and correspond to a unique injection device 32 ordifferent combinations may be provided depending on the use andprocedure contemplated. Alternatively, the lumens 58 may be fluidlyconnected as shown such that a common therapeutic agent is dispensedfrom the injection devices 32.

In the preferred embodiment shown, the second therapeutic agent deliverytip 22 includes three spaced apart injection needles 32. The needles 32are spaced so as to deliver the therapeutic agent or agents directlyinto the tissue surrounding the ablated channel. Similar to theflexibility in the radial placement of the injection needles 32 on thesecond therapeutic agent delivery tip 22, each of the injection needles32 can be varied in diameter and length to accommodate a particularprocedure and desired therapeutic agent placement.

The design of the delivery tip 22, including the needles 32 for eachapplication is particularly important so as to enable delivery of thecorrect amount of therapeutic agents, at the correct time and at thedesired location. In the preferred TMR embodiment, it is desirable todeliver the biologic material throughout the desired region in themyocardium. For example, therapeutic agent delivery from the endocardiumto the epicardium, in a controlled manner to obtain optimum coveragewithin the tissue and within the ablated region is desirable. For thisapplication, typical injection needles 32 having open orifices at theirdistal ends or tip do not appear to provide the desired coverage withinthe TMR treated tissue. Thus, the distal end of each needle 32 is cappedor occluded while providing the dispensing opening or ports 62 along theside length of the needle. In this way, the therapeutic agent is forcedout the orifices 62 in the sides of the needles 32 instead of beingdelivered in a bolus at the distal tip. Early testing has shown thisside dispensing to accomplish better dispersion and better delivery ofthe therapeutic agent into the myocardial tissue than dispensing from atraditional needle tip. Alternatively, only selected needles 32 may beend capped and provided with side delivery ports 62. Moreover, sidedelivery ports may be provided in combination with the traditionalhollow needle or even in combination with a traditional needle having apartially occluded tip.

In the preferred needle 32 design, each of the three needles is radiallyspaced so they enter the tissue centered on the ablated channel. The tipof each needle 32 is capped with a point end such as a pencil point tofacilitate penetrating the desired tissue. The point, however, can be inany form. The needles are of sufficient length so as to be able topierce the heart tissue, such as epicardium or endocardium, andpenetrate into the myocardium for proper delivery of the therapeuticagent to the desired ablated region of the myocardial tissue. For thepreferred TMR procedure, the needles 32 are fitted with a distal holethat is approximately 1.5 mm proximal from the tip of the needle. A nexthole is provided approximately 0.75 mm to 1.0 mm proximal to the firsthole and 90 degrees rotated around the longitudinal axis of the needle.A third hole is provided in the needle 32 approximately 0.75 mm to 1.0mm proximal to the second hole and 90 degrees rotated around the axis ofthe needle. A fourth and most proximal hole to the delivery tip 22 isprovided approximately 0.75 mm to 1.0 mm proximal to the third hole and90 degrees rotated around the axis of the needle 32. Although, thepreferred embodiment has four holes, the needles 32 may include anynumber of holes, including one hole or a plurality of holes. Theplurality of holes can be configured in any pattern. Preferentially, theholes are arrayed around the length of the needles 32.

A preferred method of the present invention involves using the surgicaldevice 10 to perforate the desired tissue, for example, the epicardiumof the heart, to create revascularization pathways or channels incombination with the delivery of at least one therapeutic agent.Although a preferred method for accomplishing a TMR procedure incombination with delivery of a biologic agent is described, the surgicaldevice and method of the present invention is in no way limited to suchprocedure. For example, the method is also applicable for proceduresinvolving other muscular or bodily tissues and even certain bone tissue.The device and method are further contemplated for procedures to treattumors, regions of tissue affected by poor circulation and regions oftissue affected by cancer.

In a TMR procedure, myocardial tissue is ablated into pathways orrevascularization channels which extends into the myocardium and may ormay not communicate with the ventricle. In a typical TMR procedure, achannel approximately one millimeter in diameter is lased through theleft ventricle of the heart. During lasing of the channel, themyocardium locally is disrupted which results in local healing responsewhich is believed to help promote a local angiogenic response. Therevascularization channels are created approximately one centimeterapart in the distribution of the un-revascularizable ischemicmyocardium. Approximately 10 to 12 channels are created in each regionof ischemic myocardium being treated.

The preferred method of the present invention for performing acombination myocardial revascularization procedure and delivering atherapeutic agent to a desired region of heart tissue requires thesurgical device 10 be adapted for a TMR procedure as described in thepreferred embodiment herein. The surgical device 10 is provided with theablating tip 18, the first therapeutic agent delivery tip 20 and theinjection tip 22 in the retracted position and preferably retractedwithin the stabilizing cup 16. By retracting the needles 32 within thestabilizing cup 16 or guide tubing 14, there is little chance for thesurgeon to cause inadvertent damage, either to themselves or any of theanatomic features in the patient. This is especially important in abeating heart procedure. The surgical device 10 is also connected to thelaser 40.

Once the patient is readied, a surgical opening is made and commencingwith the distal end, the guide shaft 14 is inserted into the chestcavity of a patient. The surgeon then guides the device 10 andparticularly the guide tube 14 to the desired region of tissue to betreated. The stabilizing cup 16 is then positioned against the desiredregion of the epicardium and myocardial tissue. Preferably, the surgeonadjusts the handle assembly 12 and orients the guide tube 14 such thatthe stabilizing cup 16 and the ablating tip 18 are positioned generallyperpendicular to the surface of the tissue being treated.

Once positioned, the source of ablating energy 40 such as the laser isenergized such that the ablating tip 18 is capable of ablating thetissue. The surgeon then pushes the finger slide actuator 46 forwardwhich moves the first delivery tube 28 forward and outwardly from theguide tube 14 such that the energized ablating treatment tip 18 isextended out of the guide tube and into the tissue to create the desiredchannel. As the finger slide 46 is pushed further forward, the firstdelivery tube 28 and ablating tip 18 are moved further outwardly fromthe guide tube 14 ablating a deeper channel in the tissue. Furtheradvancing of the finger slide actuator 46 engages the second deliverytube 38 so it is also moved forward and outwardly from the guide tube 14so that the injection tip 22 and the needles 32 are forced into thetissue surrounding the channel being ablated. The creation of thechannel and the engagement of the needles 32 into the surrounding tissueis a continuous operation accomplished by a single fully extended motionof the actuator 46. Alternatively, however, the actuating mechanism 44may be adapted so as to provide the surgeon the ability to haveindependent control over each function of the device 10 and particularlyover the movement of each delivery tube 28 and 38.

Once the channel is created and the needles 32 fully engaged into thetissue, the surgeon or assistant can administer and/or dispense thetherapeutic agent or agents to the first set of therapeutic agentreceiving ports 26 so that the agent or agents are delivered into thechannel. Similarly, therapeutic agents can be administered and/ordispensed into the second injection port 36 or ports so they are forcedout of the needles 32 into the tissue. Such dispensing and treatment canbe made with accommodations as to timing of the dispensing to eachlocation, amounts dispensed, combinations of agents, and the like.

One of the great advantages of the present surgical device 10 and theprocedure of the present invention is the great flexibility to adapt theprocedure and device to meet the needs of differing surgicalapplications. For example, the actuating mechanism may be reconfiguredsuch that the second delivery tube 38 is advanced into the tissue forinjection of a therapeutic agent prior to, and possibly again after,ablating tissue. The present invention also contemplates the use of thesurgical device 10 in any combination of delivery of any combination oftherapeutic agents using the first delivery tube 28 independently of thesecond delivery tube 38 and associated treatment tips 18, 20 & 22.

Another application of this invention is to provide a unique therapeuticagent such as a resorbable material directly into the ablated channel.Such material may include a collagen or other base material plug that isdoped with another therapeutic agent or therapeutic agents. The basematerial may be for purposes of retention within the channel, timereleasing the therapeutic agent, maintaining the channel, action of thebase material, or other reason. The material could be provided directlyover the fiber optic 42 in a cylindrical or partial cylindricalconfiguration lumen disposed in the first delivery tube 28. In thisconfiguration, the channel is first created with the ablating tip 18which is left in place along with the distal end of the delivery tube 28within the channel. The resorbable material can be slid down within themain lumen 52 supporting the fiber optic 42 or alternatively through asecondary lumen 54 and out a delivery tip 20 within the channel. Thefiber optic 42 could also be removed after the channel is formed in thetissue leaving a larger lumen 52 for delivery of such therapeutic agent.Similarly, the device 10 could be used to deposit an electrode, monitoror similar device into the channel while maintaining the lead within oneof the lumens 28 & 38.

If a “slotted” cylinder or lumen is used (for example, a ¾ cylinder),then when the fiber is removed, the myocardium will tend to collapse theresorbable implant. The material chosen could be collagen for example oranother material that is readily resorbed by the body over time. Inaddition, the resorbable material could be doped or impregnated with adesirable therapeutic agent or biologic material. These could beangiogenic factors to enhance the angiogenic response and also toprovide a time release of the appropriate factor. As an example, stemcells or growth factors or combinations of these could be used toimpregnate the resorbable implanted material.

The various therapeutic agent delivery embodiments could also be used incombination with one another. For example, a therapeutic agent deliverymanifold could be supplied to provide an angiogenic compound into themyocardium surrounding the channel. The manifold may be fitted with aplurality of needles or other injection devices. In addition, aresorbable material could be provided directly within the myocardiumthrough another lumen passing through or adjacent the manifold. In thisway, the material around the channel could provide an immediate supplyof the desired biologic agent to enhance the angiogenic response in theshort term. A bioresorbable impregnated implanted material could alsoadvantageously be used to provide a time dependent release of theangiogenic or other desired agent for a longer term response.

Further details of the present invention, including various methods ofusing the present invention may be found with reference to the DetailedDescription of Embodiment section of U.S. Pat. No. 5,713,894 issued onFeb. 3, 1998 to Murphy-Chutorian and Harman and to the DetailedDescription of the Preferred Embodiment section of U.S. Pat. No.5,976,164 issued on Nov. 2, 1999 to Bencini et al. of which both areincorporated in their entirety herein by reference.

While the principles of the invention have been made clear inillustrative embodiments and illustrations, those of skill in the artwill appreciate that the present invention is capable of various otherimplementations and embodiments that operate in accordance with thedescribed principles and teachings. For example, many of the componentsmay be made from various materials and may be interconnected in variousways. Moreover, the arrangement of the elongated multi-lumen tubes andguide tube may be accomplished by using differing tubular shapes or withdiffering bore configurations and diameters. This is particularlycontemplated as each surgical procedure may require a differenttreatment means and also differing surgical procedures. The handle maybe made of materials other than plastic and may be configureddifferently to provide alternative designs. Accordingly, this detaileddescription is not intended to limit the scope of the present invention,which is to be understood by reference the claims below.

As also described, the preferred embodiment of the present invention isintended for use with a laser as the source of ablating energy. AHolmium or excimer laser is particularly suited to the presentinvention. However, any suitable laser source, pulsed or otherwise,could provide laser energy to the laser delivery means of the presentinvention for performing the method of the present invention. Likewise,the catheter and surgical equipment, including laser delivery means,referred to in the present document as well as that known and used inmedicine and other disciplines today and in the future, will be includedin the scope of this disclosure. Such laser delivery means include, butare not limited to, individual optical fibers as well as bundles offibers, rods, mirror configurations and other laser delivery means withand without a focusing lens and the like. It will also be understoodthat the apparatus and method of the present invention as describedherein, including novel combinations or use with any conventionalmechanism or method which are known to those skilled in the art, areincluded within the scope of this invention.

It will further be understood that while the present invention has beengenerally described for performing TMR on myocardial heart tissue, thesurgical device and methods described herein are equally intended foruse in any suitable procedure, including but not limited to procedureswhere tissue ablation and therapeutic agent delivery are desired. Suchtreatments include but are not limited to visualization, biopsy, thetreatment of tumors, cancers and other growths. The device is alsosuitable for stimulation procedures wherein tissue is ablated to createzones or pockets, optionally interconnected at least initially by smallchannels ablated through the tissue, for the introduction of blood-bornegrowth or other therapeutic agents or healing factors and stimulatedcapillary growth surrounding the lased zones or pockets to create anincreased supply of oxygen to the tissue and thus a revitalization ofthe tissue.

1. A method for ablating a channel and delivering a therapeutic agentinto a desired region of tissue, comprising: (a) providing a surgicaldevice having an elongated multi-lumen tube with a proximal end inconnection with a control handle assembly and extending to a distaltreatment end adapted for ablating and delivering the therapeutic agentto the tissue, said multi-lumen tube having a tissue ablating assemblyextending through a first lumen of the multi-lumen tube and atherapeutic agent delivery assembly incorporating a second lumen of themulti-lumen tube, wherein the ablating assembly has a proximal end inconnection with a source of ablating energy and extending distally to anablating tip and the therapeutic agent delivery assembly has atherapeutic agent receiving port at a proximal end and extends distallyto an injection tip and wherein the ablating tip and injection, tip aredisposed such that the therapeutic agent can be delivered into tissuesurrounding a channel formed by the ablating tip; (b) positioning thetreatment end adjacent to the desired region of tissue; (c) energizingthe source of ablating energy such that the ablating tip is capable ofablating the tissue; (d) advancing the ablating tip to form a channel inthe tissue; and (e) dispensing the therapeutic agent from the injectiontip into the tissue adjacent the channel.
 2. The method of claim 1,wherein the ablating energy is a laser and the ablating tip is a lasingtip.
 3. The method of claim 1, further comprising dispensing thetherapeutic agent into the channel.
 4. The method of claim 1, whereindispensing a therapeutic agent comprises dispensing the agent intomultiple locations adjacent to the channel.
 5. The method of claim 1,wherein the injection tip in the form of a needle.
 6. The method ofclaim 5, wherein the device further comprises a second and third needleand the three needles are radially spaced so they enter the tissuesurrounding and centered on the formed channel.
 7. The method of claim6, wherein each of the needles comprises a plurality of holes arrayedalong the length of the needle.
 8. The method of claim 1, wherein theregion of tissue comprises myocardium.
 9. The method of claim 1, whereinthe therapeutic agent comprises stem cells.
 10. A method for performinga combination myocardial revascularization procedure and delivering atherapeutic agent to a desired region of heart tissue, comprising thesteps of: (a) providing a surgical device having an first elongatedmulti-lumen tube with a proximal end in connection with a control handleassembly and extending to a distal treatment end, said first multi-lumentube having a tissue ablating assembly supported in a first lumen of themulti-lumen tube and a therapeutic agent delivery assembly supported ina second lumen of the multi-lumen tube, wherein the ablating assemblyhas a proximal end in connection with a source of ablating energy andextending distally to an ablating tip for creating a channel in thetissue and wherein the therapeutic agent delivery assembly has aproximal end that is connectable with a source of the therapeutic agentand extending distally to a delivery tip disposed proximally to theablating tip such that the therapeutic agent can be delivered from thesource and into the channel, said surgical device further comprising asecond elongated multi-lumen tube connectable with a second therapeuticagent at a proximal end and extending to an injection tip and adaptedfor delivering the second therapeutic agent from the source to theinjection tip for dispensing into the tissue; (b) positioning thetreatment end adjacent the desired region of tissue; (c) energizing thesource of ablating energy such that the ablating tip is capable ofablating the tissue; (d) advancing the ablating tip into the tissue toform a channel in the tissue; (e) advancing the injection tip into thedesired region of tissue; and (f) dispensing the therapeutic agent fromthe delivery tip into the channel.
 11. The method of claim 10, whereinthe step of advancing the ablating tip comprises advancing the firstmulti-lumen lumen tube relative to the second multi-lumen lumen tube.12. The method of claim 10, wherein the step of advancing the ablatingtip comprises advancing the ablating tip outwardly relative to theinjection tip.
 13. The method of claim 10, further including the step ofextending the first multi-lumen lumen tube relative to the secondmulti-lumen lumen tube.
 14. The method of claim 10, further comprisingthe step of dispensing a therapeutic agent from the agent injection tipinto the desired region of tissue.
 15. The method of claim 10, whereinthe ablating energy is a laser and the ablating tip is a lasing tip. 16.The method of claim 10, wherein the step of dispensing the therapeuticagent comprises dispensing a first therapeutic agent through the firstdelivery tip and a second therapeutic agent through the injection tip.17. The method of claim 10, wherein the injection tip is advanced intothe desired region of tissue prior to advancing the ablating tip intothe tissue to form the channel.
 18. The method of claim 10, wherein thestep of advancing the injection tip into the desired region of tissueand a step of injecting the second therapeutic agent into the desiredregion of tissue occur prior to the step of advancing the ablating tipinto the tissue.
 19. The method of claim 10, further comprising the stepof dispensing a first therapeutic agent from the delivery tip into thechannel and dispensing a second therapeutic agent from the injectionassembly into the desired region of tissue.
 20. The method of claim 10,wherein the step of dispensing a therapeutic agent further comprisesdispensing the agent into the channel formed by the ablating tip andinto tissue adjacent the channel.
 21. The method of claim 10, furtherincluding the step of retracting the ablating tip from the tissue.
 22. Amethod for performing a combination myocardial revascularizationprocedure and delivering a therapeutic agent to a desired region ofheart tissue, comprising: positioning a surgical device having aproximal end with a control handle assembly and a distal end connectedto a treatment assembly, such that the distal end of the treatmentassembly is positioned adjacent to the desired region of heart tissue;energizing a laser such that an ablating tip in the treatment assemblyis capable of ablating the heart tissue; advancing the ablating tip intothe heart tissue and ablating tissue to form a channel in the hearttissue; advancing a plurality of needles from the treatment assemblyinto the desired region of tissue; and dispensing the therapeutic agentfrom a source in the surgical device through the plurality of needlesdirectly into the heart tissue surrounding the channel.
 23. The methodof claim 22, wherein the plurality of needles are radially spaced sothat they are advanced into the tissue surrounding and centered on thechannel.
 24. The method of claim 22, wherein each of the needlescomprises a plurality of holes arrayed along the length of the needle.25. The method of claim 24, wherein the tip of each of the needles iscapped with a point.
 26. The method of claim 22, wherein the pluralityof needles is three needles.
 27. The method of claim 22, wherein thetherapeutic agent comprises stem cells.
 28. The method of claim 22,wherein the advancement of the ablating tip and the needles into theheart tissue is a continuous operation accomplished by a single fullyextended motion of an actuator located in the control handle assembly.